June 2022 FDA Recall Draximage Maa by Jubilant Draximage Inc
D-1189-2022 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Jubilant Draximage Inc on June 16, 2022 for the product Draximage Maa. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1189-2022

Reason for Recall
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Initiated
06-16-2022
Reported
07-20-2022
Quantity
519 cartons/30 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90455
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jubilant Draximage Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to retailers nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-25-2023
Product Description About Product Description
Full technical description of the product.
Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufactured for Jubilant Draximage Inc. Kirkland, Canada, NDC 65174-270-30.

Batch or Lot Expiration Information

Lot# 1H005, exp. date Nov 30, 2023

Affected Packages Involved in this Recall

65174-270-30 Draximage Maa